CRIPB-13-002Évaluation du milieu vaginal: Protéines, Cytokines et Microbiologie chez les femmes asymptomatiques et symptomatiques
Cette étude observationnelle vise à déterminer les types de cytokines présents dans le vagin de femmes en bonne santé et de celles atteintes de vulvodynie, de vaginites fongiques et bactériennes récurrentes, et d'accouchement prématuré, afin de comprendre l'environnement vaginal dans ces différentes conditions.
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveMaladies génito-urinaires+14
+ Maladies Génitales
+ Infections bactériennes et mycoses
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 1 avril 2013
Date à laquelle le premier participant a commencé l'étude.Our approach specifically targets the evaluation of the proteins and cytokines present and the bacteriological analysis of the microflora in the vaginal milieu. Conjectures: An initial insult in the vagina (possibly involving a bacterial, viral or fungal organism or their products) causes modifications in the vaginal milieu The vaginal milieu responds to the insult by developing an inflammatory reaction characterized by cytokine and protein production Long lasting or repetitive insults maintain biochemical changes in the vaginal milieu producing a reaction, chemical irritation or micro flora alteration by changes in proteins and/or abnormal protein production Those changes eventually result in hypersensitivity, irritation, burning, and pain manifested in patients with vulvodynia. And those changes may also result in the recurrence of fungal or bacterial infections Those changes may also contribute to initiate the cascade of premature events conducting to cervical effacement and dilation observed in preterm labor The conjectures will be investigated by using a multidisciplinary approach including: microbiology, proteomics and cytokines evaluation of the vaginal milieu. Specifically we will be comparing an asymptomatic female population to serve as a baseline to patients affected by vulvodynia, recurrent fungal or bacterial vaginosis and/or pregnancy. This is a prospective, descriptive study of about 550 women age 12 to 75 years. There will be four groups: 1) Asymptomatic healthy women, 2) Women being seen for any gynecological vulvovaginal condition, and 3) Pregnant women who are asymptomatic and healthy, and 4) Pregnant women have any gynecological vulvovaginal condition. We will evaluate the following: Types of cytokines normally present in women and in patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor Normal microbiology flora in women and variations present in the vaginal milieu in these patients The presence of normal and atypical proteins in the vaginal milieu of healthy women and patients with vulvodynia, recurrent fungal and bacterial vaginosis and preterm labor Informed consent will be obtained and documented for participation in the study Comprehensive history assessment of environmental factors, topical vulvovaginal issues and co morbid conditions as defined in the exclusion criteria. Pelvic examination to obtain two samples via cotton swabs for proteomics, cytokines, vaginal lactobacillus from vaginal secretions. A. Swab procedure: The cotton swabs (2) will be introduced only in the middle vagina, one at the time, no other areas will be sampled. B. Swab processing One swab will be placed in a special room temperature solution. This de-identified swab will be mailed for Lactobacillus. The second de-identified swab is to be place in 2 separated micro-containers in Liquid Nitrogen Containers (one for cytokines and one for Proteomics). When 50 samples are completed they will be processed at TTUHSC Permian Basin campus, with the Proteomics testing being done in Lubbock. Therefore, there are 3 samples, each processed differently. Data will be recorded in a confidential manner with no personal identifiers, only an assigned study subject number. As such, the de-identified data may serve as a database for additional studies. The computer used will belong to TTUHSC and be password protected, access limited to only authorized personnel. Consent forms will be stored separately from the study data in the research office.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.550 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 21 à 75 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: All patients willing to participate, and give informed consent, and Asymptomatic, non-pregnant, healthy women ages 21 to 75 years with no previous history of any chronic or recurrent vulvovaginal condition who attend our clinical offices for their annual well-woman physical examination. Non-pregnant women ages 21 to 75 years being evaluated for any gynecological vulvovaginal condition. Pregnant women ages 21 to 75 years who are both asymptomatic and healthy Pregnant women ages 21 to 75 who have any gynecological vulvovaginal condition Exclusion Criteria: Asymptomatic patients ages < 21 or > 75, or symptomatic patients ages < 21 or > 75 years. Patients diagnosed with cancer or having any medical condition that is not under control including: diabetes mellitus, hypertension, collagen disease, hemoglobinopathy, renal insufficiency, depression, anxiety, psychosis and panic attacks Patients unable to follow the protocol or unwilling to participate
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.4 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site